Natural History Study of Patients With Chronic Myelogenous Leukemia

Chronic Myeloid Leukemia (CML) Cohort

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00429910

Enrollment

Registered

2007-02-01

Start date

2003-02-28

Completion date

2005-09-30

Last updated

2017-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, meningeal chronic myelogenous leukemia

Brief summary

RATIONALE: Gathering information about patients with chronic myelogenous leukemia may help doctors learn more about the disease and find better methods of treatment and on-going care. PURPOSE: This natural history study is collecting health information and disease-related information over time from patients with newly diagnosed chronic myelogenous leukemia.

Detailed description

OBJECTIVES: * Determine the impact of current procedures for diagnosis, management, and follow-up on disease status of patients with newly diagnosed chronic myelogenous leukemia (CML). * Determine the natural history of patients with CML who achieve response to imatinib mesylate. * Determine the health perceptions, symptoms, insurance issues, and work issues of these patients. * Determine whether medication compliance and planned dose reduction affect imatinib mesylate effectiveness in these patients. * Determine the molecular and biologic factors associated with disease progression and good and poor response to imatinib mesylate in these patients. OUTLINE: This is a longitudinal, prospective, cohort study. Patients complete quality of life, functional status, medical and treatment history, and medication questionnaires at baseline and then every 6 months for 5 years. Blood samples are collected at baseline and then every 6 months for 5 years. Specimens may be examined in the future in gene array studies and mutation analyses.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

Healthy volunteers

Inclusion criteria

Age 18 years and over Diagnosis within one year of enrollment

Design outcomes

Primary

Measure	Time frame
Impact of current procedures for diagnosis, management, and follow-up on disease status	5 years
Natural history of patients with chronic myelogenous leukemia who achieve response to imatinib mesylate	5 years
Health perceptions, symptoms, insurance issues, and work issues	5 years
Affect of medication compliance and planned dose reduction on imatinib mesylate effectiveness	5 years
Molecular and biologic factors associated with disease progression and good and poor response to imatinib mesylate	5 years

Countries

United States

Outcome results